FDA Announces More Metformin Recalls Due to Carcinogen

Metformin recalls

The U.S. Food and Drug Administration (FDA) has announced more Metformin recalls due to potential contamination with the carcinogen N-Nitrosodimethylamine (NDMA).  The latest recall is the fifth involving extended-release Metformin tablets.  For consumers who rely on Metformin to manage their Type 2 diabetes, Metformin recalls are reasonably concerning.  Here is what we know about the latest Metformin medication recalls.

Information about New Metformin Recalls

The latest Metformin recall involves Metformin manufactured by Lupin Pharmaceuticals Inc.  The recall includes Metformin Hydrochloride Extended-Release (ER) Tablets USP.  This product is the generic equivalent of Fortament.  Consumers can identify the recalled Metformin by the following:

  • Metformin Hydrochloride Extended-Release Tablets USP
  • 500 milligram tablets
  • Lot number: G901203
  • NDC: 68180-336-07
  • Expiration: 12/2020

According to the FDA Company Announcement, tests show that this lot of Metformin has levels of NDMA that exceed the Acceptable Daily Intake Limit.  While the FDA has not received any reports of adverse events related to this product, the presence of NDMA is a concern.  NDMA is a probable human carcinogen, which means that the substance could cause cancer.

Consumers who take Metformin subject to Metformin recalls should talk to their healthcare provider about continuing their medication or choosing an alternative.  Consumers who experience adverse side effects while taking Metformin should also file a complaint through the MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

The Lupin Pharmaceuticals recall adds to the ongoing list of Metformin recalls.  Current recalls also include Metformin manufactured and distributed by:

  • Apotex Corp.
  • Teva Pharmaceuticals USA, Inc.
  • Marksans Pharma Limited
  • Amneal Pharmaceuticals LLC

Information about Metformin

Metformin is a prescription drug used to control blood glucose (blood sugar) levels in adults with Type 2 diabetes mellitus.  Numerous pharmaceutical companies manufacture Metformin and sell it under brand and generic names.  In 2019, there were an estimated 21 million prescriptions for Metformin extended-release tablets.  That accounts for around one-fourth of all Metformin prescriptions.  Furthermore, Metformin is the fourth most-prescribed drug in the United States.

With so many people relying on Metformin to maintain their health, the increase in Metformin recalls is causing concern.  Many consumers are worried about what they will do if their variety of Metformin is recalled.  The FDA urges consumers to talk to their healthcare provider.  In a statement, the FDA says,

“There are additional companies that manufacturer ER metformin and supply a significant portion of the U.S.  market, whose products are not being recalled at this time.”

The FDA is asking pharmaceutical companies that manufacture Metformin ER to evaluate their products and test for NDMA.  Companies that find NDMA levels above acceptable levels should inform the FDA and halt production and distribution.

Learn More about Medication Recalls

Millions of people rely on pharmaceutical products to maintain their health and wellness.  Metformin recalls are only one example of a problem that is currently plaguing the pharmaceutical industry.  NDMA has been discovered in various medications, including Metformin, Zantac and Valsartan.

Unfortunately, most consumers are caught off-guard when their medication is recalled.  Many consumers have taken these medications for years – sometimes decades.  Finding out that you may have been unknowingly exposing yourself to a probable human carcinogen is reasonably upsetting.  It is only natural that you have questions and need answers.

If you have questions about a medication or medical device recall, contact Drug and Device Watch.  Our legal professionals can help answer your questions and offer guidance if you have been impacted by a defective or dangerous drug.  Learn more by completing our online contact form.  You can also give us a call at 1-888-458-6825.